An Efficacy Study to Evaluate Alfuzosin to Treat Men With Erectile Dysfunction and Mild Lower Urinary Tract Symptoms

A Phase 3, Double Blind, Placebo-Controlled, Crossover Study to Evaluate the Efficacy of Alfuzosin in Treating Men With ED and Mild LUTS.

The purpose of this study is to assess the effect of Alfuzosin in treating Erectile Dysfunction in men with mild lower urinary tract symptoms based upon a change from baseline in erectile function (EF) domain of International Index of Erectile Function (IIEF).

This protocol is a placebo-controlled, double-blind, crossover trial. Patients will be screened and then randomized to Group A or Group B at a 1:1 ratio to receive a placebo tablet once daily or Alfuzosin (10 mg) daily for 12 weeks. Patients will then crossover with the original placebo group receiving Alfuzosin for 12 weeks and the original Alfuzosin group receiving placebo. At every visit the patients will complete an IIEF and an AUA symptom index.

Inclusion Criteria:

• Male, 30-69 years of age
• Has mild to moderate Erectile Dysfunction with a score < 25 on EF domain in IIEF
• AUA score of less than or equal to 14
• Negative urinalysis with no evidence of a Urinary Tract Infection

Exclusion Criteria:

• Blood pressure < 90/50 or > 170/110
• Neurological disorder (MS, SCI, CVA, Parkinson's disease, ALS)
• Diabetes Mellitus
• History of PSA > 10
• History of confirmed or suspected prostate cancer
• History of Moderate/Severe Hepatic Insufficiency defined as > 2X ULN
• On Alpha Blocker or PDE 5 inhibitor within 2 weeks of randomization
• Receive treatment with other investigational agents within 30 days prior to enrollment